VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer

Incidents per State

State Total
72,296
AK1,638
AL5,339
AR3,412
AS44
AZ13,316
CA58,147
CO11,002
CT7,824
DC1,626
DE1,670
FL36,235
FM3
GA13,429
GU82
HI2,195
IA4,332
ID2,473
IL19,261
IN22,568
KS4,284
KY6,945
LA4,714
MA13,886
MD11,901
ME2,997
MH8
MI17,865
MN11,345
MO8,919
MP30
MS2,676
MT2,147
NC15,401
ND1,273
NE2,732
NH2,859
NJ17,232
NM3,702
NV4,071
NY32,763
OH18,072
OK5,940
OR7,954
PA22,457
PR2,104
QM2
RI1,911
SC6,055
SD1,133
TN8,691
TX34,122
UT4,023
VA13,944
VI49
VT1,661
WA13,811
WI10,395
WV2,220
WY805
XB5
XL1
XV2

ID: 1489845
Sex: F
Age:
State: NJ

Vax Date: 05/01/2021
Onset Date:
Rec V Date: 07/21/2021
Hospital:

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Symptom List:

Symptoms: Started with 1st dose. Muscle twitches in lower legs. In the last 2 months, after second dose, increasing.; Started with 1st dose. Muscle twitches in lower legs. In the last 2 months, after second dose, increasing.; Keeping me up at night; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 58-years-old female (Non-pregnant) patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: FR28744), via an unspecified route of administration, administered in am left on 01May2021 at 12:00 (age at the time of vaccination 58-years-old), as a single dose for COVID-19 immunization. The patient's medical history included Known allergies from Aleve, and prior to vaccination, the patient diagnosed with COVID-19. The patient's concomitant medication included losartan (LOSARTAN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date, the patient experienced started with 1st dose, muscle twitches in lower legs, in the last 2 months, after second dose, increasing; and keeping me up at night. Since the vaccination, the patient has not been tested for COVID-19. The outcome for all the events was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds: LOSARTAN

Current Illness:

ID: 1489846
Sex: M
Age:
State: LA

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 07/21/2021
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Symptoms: pain in the upper arm where he got the shot after the first dose; This is a spontaneous report received from a contactable consumer. A contactable consumer reported that, a 59-year-old male consumer (patient) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8732; Expiration Date: 01Apr2021), dose 1 via an unspecified route of administration, administered in right upper arm deltoid area on 01Apr2021 at 10:30 (at the age of 59-year-old) as a DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included neck surgery from an unknown date and unknown if ongoing he has had surgery on his neck, but this was before the shots and related to his disability. It was done on C5, C6, C7, he had a discectomy done in either 2017-2018. The patient's concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) were none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Prior Vaccinations (within 4 weeks) and events following prior vaccinations were none. Patient's Medical History (including any illness at time of vaccination) were none. The patient experienced pain in the upper arm where he got the shot after the first dose on an unspecified date in Apr2021. It was reported that, he received 2 doses of the COVID Vaccine in Apr2021 and is still having pain in the upper arm with numbness and tingling. The patient confirmed it is the Pfizer COVID Vaccine. he was disable but use to work as a medical tech. Reporter wanted to know what he should do, where does he go from here. No treatments were reported for the event. Events did not require a visit to the Emergency Room or Physician Office (his next step would be to call his primary care). Relevant Tests done were none. Reporter seriousness for the event was Unspecified. Outcome of the event was not recovered. Follow-up actions are needed. Further information has been requested.

Other Meds:

Current Illness:

ID: 1489847
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/21/2021
Hospital:

Vax Type:
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Symptoms: Bad nose with shingles; Bad nose with shingles; This is a spontaneous report from a contactable consumer (patient) or other non health care professional. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration in 2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing diabetes mellitus. The patient's concomitant medications were not reported. The patient experienced bad nose with shingles in 2021. She was calling because she said she had the first dose of the shot in April and she started having pain and she said she was the diabetic (Intent of medical history) and she said ever since she got the shot she can't do the insulin injection (Further clarification unknown hence captured suspect as Unspecified medication) all because it was hurting and burning so bad but she said after she got the second shot she was started feeling better but she was still can't do her injections because she said it hurts and feels so bad and she has recently bad nose with shingles and she says she had believes that it is because of the Covid vaccine and she was calling to report those events. The outcome of the events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness: Diabetic

ID: 1489848
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/21/2021
Hospital:

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Symptoms: her sister's left foot had swelled after getting the vaccine; This is a spontaneous report received from a contactable consumer. This consumer reported for a female patient (owner's sister). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration on an unspecified date, at unknown dose single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. When the reporter was at a consignment store and was talking to the owner about the vaccine her sisters left foot had swelled after getting the vaccine (unknown date). The outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1489849
Sex: F
Age:
State: IL

Vax Date: 06/17/2021
Onset Date:
Rec V Date: 07/21/2021
Hospital:

Vax Type:
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Symptoms: Sore arm; This is a spontaneous report from a contactable consumer (patient reported for herself). A 60-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0180), dose 1 via an unspecified route of administration, administered in Arm Left on 17Jun2021 (Age at vaccination:60 years) as DOSE 1, SINGLE for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient medical history was penicillin allergy and concomitant medications were not reported. The patient previously took allergyx. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. The patient had not received other medications in two weeks. On an unspecified date, after the 1st shot she experienced mild side effects of sore arm. The event outcome was unknown.

Other Meds:

Current Illness:

ID: 1489850
Sex: M
Age:
State: IL

Vax Date: 04/30/2021
Onset Date: 07/09/2021
Rec V Date: 07/21/2021
Hospital:

Vax Type:
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Symptoms: For after being vaccinated against Covid-19/Patient got tested for covid on 09Jul2021/he was positive for covid; For after being vaccinated against Covid-19; This is a spontaneous report from a contactable consumer. This contactable consumer (patient's wife) reported for a 78-year-old male patient. A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: ER8736; Expiration Date: 31Jul2021), dose 2 via an unspecified route of administration, administered in Arm on 30Apr2021 10:30 (age at the time of vaccination was 78-year-old) as single dose for COVID-19 immunization. Medical history included COVID-19 from Dec2020 to Jan2021 (Patient had covid in late Dec 2020 to early Jan 2021). There were no concomitant medications. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0151; Expiration Date: on an unspecified date in Jul2021), dose 1 via an unspecified route of administration, administered in Arm on 09Apr2021 10:30 as single dose for COVID-19 immunization. The reporter reported that she and her husband both had COVID in late Dec2020 to early Jan2021. she stated she and her husband both received both doses of the Pfizer covid vaccine. Reporter's husband is the patient. Patient was now tested positive for COVID again. Because it was a mild case of COVID, the CDC does not care. Reporter was very aggravated because they had their grandkids over that past weekend and exposed them to COVID. Reporter and patient thought they were safe to have family over because they received the COVID vaccine. Now patient has tested positive for COVID. The patient got tested for COVID on 09Jul2021. The hospital called yesterday, 11Jul2021, and told patient he was positive for COVID and cancelled his surgery. The patient was supposed to have a total knee replacement on 12Jul2021. Prior to patient's knee replacement, patient had got a big check-up. The doctors did an EKG, and everything was fine. The doctor told patient he was in the best health out of anyone his age. The reporter stated she was going to go get tested for COVID. The patient underwent lab tests and procedures which included electrocardiogram: fine on 09Jul2021, sars-cov-2 test: positive on 09Jul2021. Outcome of the events was reported as unknown. Follow-up attempts are needed. Further information is requested.

Other Meds:

Current Illness:

ID: 1489851
Sex: M
Age:
State:

Vax Date: 07/08/2021
Onset Date: 07/01/2021
Rec V Date: 07/21/2021
Hospital:

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Symptoms: fever of 100; This is a spontaneous report from a non-contactable consumer (patient). A 38-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 08Jul2021(at the age of 38 years old) as single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient stated he got the COVID-19 shot yesterday, has a slight fever of 100 stated he is not sick just having COVID shot symptoms. The patient underwent lab tests and procedures which included body temperature:100 on an unspecified date on Jul2021 (slight fever of 100). Outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1489852
Sex: U
Age:
State: NC

Vax Date:
Onset Date:
Rec V Date: 07/21/2021
Hospital:

Vax Type:
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Symptoms: I have had migraines every single day since my first, which worsened with the second.; This is a spontaneous report received from a Pfizer Sponsored Program Pfizer.com - General Company Information. A contactable consumer reported that a patient of unspecified age and gender received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose and second dose via an unspecified route of administration on an unspecified date (BNT162B2, solution for injection, Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient have had migraines every single day since first, which worsened with the second on an unspecified date in 2021. The outcome of event was unknown. Information about batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1489853
Sex: F
Age:
State: TN

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 07/21/2021
Hospital:

Vax Type:
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Symptoms: Blood clot in her legs; This is a spontaneous report from a contactable other healthcare professional. A 40-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization and tofacitinib citrate (XELJANZ XR), oral from 2020 (Batch/Lot number was not reported; Expiration Date: 28Feb2023) to 2021, at 11 mg, 1x/day for psoriatic arthritis. It was unknown if the patient was pregnant. The patient medical history was not reported. Concomitant medications included metoprolol succinate, rivaroxaban (XARELTO) (20 mg tablet) and paracetamol (TYLENOL) (325 mg tablet). On an unspecified date in May2021, the patient experienced blood clot in her legs. The patient reported that she developed blood clots in her legs, went to the emergency room in early Jun2021. She further stated that she has been followed by vascular MD that currently have her off all her prescription medications except the anticoagulants. She also stated that the doctor said it was hard to tell what caused the clots since she was taking birth control, xeljanz and also had her covid vaccine around the same time. She was off xeljanz until cleared by vascular MD. Prescribing MD aware. The clinical outcome of the event was reported as not recovered. Follow-up attempts are needed. Information on the lot/batch number has been requested.

Other Meds: METOPROLOL SUCCINATE; XARELTO; TYLENOL

Current Illness:

ID: 1489854
Sex: F
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 07/21/2021
Hospital:

Vax Type:
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Lot:
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Symptom List:

Symptoms: right ear itching and burning and then the skin started to crack; right ear itching and burning and then the skin started to crack; right ear itching and burning and then the skin started to crack; her other ear was burning, red, felt hot and started cracking again; her other ear was burning, red, felt hot and started cracking again; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer or other non hcp reported that a female patient (reporter's sister) of an unspecified age received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced right ear itching and burning and then the skin started to crack, her other ear was burning, red, felt hot and started cracking again. The outcomes of events were unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1489855
Sex: F
Age:
State: ID

Vax Date: 04/27/2021
Onset Date: 05/01/2021
Rec V Date: 07/21/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
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Vax Site:

Lab Data:

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Symptom List:

Symptoms: Shingles; This is a spontaneous report from a contactable consumer. This 69-year-old Female consumer (patient) reported for herself that: received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, dose 1 (Lot Number: ER8736 expiry date was not reported) via an unspecified route of administration at arm Left on 27Apr2021 (at the age of 69-years-old) as a single dose, dose 2 (Lot Number and expiry date was not reported) via an unspecified route of administration on 19May2021 as a single dose, for covid-19 immunisation. Medical history included herpes zoster from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was reported that the patient received vaccine on 19May2021 and got shingles on 27May2021 or 28May2021 (conflictingly reported). The patient reported that It pretty much went away she still has some tingling. The patient received treatment with the prescription she gave her and over the counter ibuprofen. Prescription includes gabapentin 300 mg, capsule, she took it whenever she needed. It was not helping she said she could start taking it every four hours. Outcome of the event was recovering. Follow-up attempts are needed. Information on Lot/Batch number can be requested

Other Meds:

Current Illness:

ID: 1489856
Sex: M
Age:
State: FL

Vax Date: 04/16/2021
Onset Date: 07/01/2021
Rec V Date: 07/21/2021
Hospital:

Vax Type:
Manufacturer:
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Symptom List:

Symptoms: Got 2 doses of the vaccine tested positive with the COVID-19 Virus; breakthrough infection/patient was just diagnosed last week Friday; Got 2 doses of the vaccine tested positive with the COVID-19 Virus; breakthrough infection/patient was just diagnosed last week Friday; Patient not feeling good; Severe Cold and Flu; Severe Cold and Flu; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EN6208), dose 1 via intramuscular route, administered in arm left on 26Mar2021 at 09:30 (at the age of 48-year-old) as dose 1, single and dose 2 (Batch/Lot Number: ER8729) via intramuscular route, administered in arm right on 16Apr2021 at 09:30 (at the age of 48-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included Levocetirizine as allergy medication. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unspecified date in Jul2021, the patient experienced got 2 doses of the vaccine tested positive with the covid-19 virus; breakthrough infection/ patient was just diagnosed last week Friday and on an unspecified date in 2021, the patient not feeling good, severe cold and flu. The clinical course of the events was reported as: he mentioned that he got 2 doses of the vaccine and he was really glad to have the vaccine but unfortunately after that (incomplete sentence), well actually he got the 1st dose last 26Mar and the 2nd dose last 16Apr but unfortunately after a month he was tested positive with the COVID-19 Virus. He stated, he got diagnosed just last week and his shot were between 26Mar and 16Apr of this year and he did not have COVID before this ever. He stated that right now (as reported) since he was not feeling good he had some over the counter medication but when he first came down with this (COVID-19 Virus), the only thing I was taking was allergy medication. I take Levocetirizine (Intent: treatment), 5 mg and I take I once a day in the evening. Laboratory test: included sars-cov-2 test: positive on an unspecified date in Jul2021 and he stated, not for at least, he wanted to say 4 or 5 months, it was the last time he had lab test. Treatment in response to events: he stated, yes, he started on Nyquil and Dayquill and they were severe cold and flu. He took some Aspirin also. He added, that was everything, he just wanted to call and let Pfizer know what happened to see if they ever wanted more information. The outcome of the events was unknown. Product quality complaints: Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot EN6208 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EN6208, fill lot EN5338, and the formulated drug product lot EN5329. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.

Other Meds: LEVOCETIRIZINE

Current Illness:

ID: 1489857
Sex: M
Age:
State:

Vax Date: 07/01/2021
Onset Date: 07/01/2021
Rec V Date: 07/21/2021
Hospital:

Vax Type:
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Symptom List:

Symptoms: Rash on his arm; This is a spontaneous report from a non-contactable consumer (patient). A 26-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported) via an unspecified route of administration on Jul2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced rash on his arm on Jul2021. The patient unsure if this has something to do with the vaccine or not and want to clarify if rashes on the arm is a common side effect. Patient also wanted to know, is still safe to get a second dose of BNT162B2. The outcome of the events was unknown. No follow-up attempts are possible; No further information is expected.

Other Meds:

Current Illness:

ID: 1489858
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/21/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: shingles; This is a spontaneous report from a non-contactable consumer (patient daughter) received via a sales representative. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date, as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date, as dose 1, single for COVID-19 immunisation. The patient experienced shingles after second dose of COVID vaccine on an unspecified date. The outcome for the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1489859
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/21/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Vax Site:

Lab Data:

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Symptom List:

Symptoms: Experiencing headache; Super congestion; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The consumer stated that the patient was supposed to get his second dose of vaccine on Monday (12Jul2021) but he had been experiencing headache and super congestion since an unspecified day. On 15Jul2021, the patient did not have fever and his temperature was 98.7 in the morning. The consumer wanted to know if congestion was part of the side effects of the COVID vaccine. The outcome of the events was not recovered. Information on lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1489860
Sex: F
Age:
State:

Vax Date: 06/22/2021
Onset Date:
Rec V Date: 07/21/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
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Lab Data:

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Symptom List:

Symptoms: her SED rate went from 30 to 130; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 22Jun2021 as dose 1, single and received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 12Jul2021, as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, patient had a blood test done before she received the vaccine. On an unspecified date of 2021, patient had another blood test done after she received the vaccine, and her erythrocyte sedimentation rate (SED) went from 30 to 130. Patient questioned that, has this happened before and was informed that there was no information regarding a change in lab results with the Pfizer Covid-19 vaccine, Survey offered. The outcome of the event was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1489861
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/21/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

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Symptom List:

Symptoms: seizure; Initial information received on 12-Jul-2021 regarding an unsolicited valid serious case received from a pharmacist via call center via Regulatory Authority (Reference number- 00676744). This case involves an female patient (unknown demographics) who experienced seizure when received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL]. The patient's past medical history, vaccination, concomitant and family history were not provided. Past vaccination include ADACEL 10 years ago for prophylactic vaccination and did not have any side effect or seizures attack related to the vaccine for the past 10 years. On an unknown date, the patient received a booster dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date the patient developed a serious seizure (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. This event was assessed as medically significant. Laboratory details were not reported. It was reported that ''what to advise patient after informing her medical provider? does patient have to undergo tests through provider to rule out any adverse reaction from the vaccine due to her current seizure disorder. If Pharmacist calls in verify if asking of drug interactions between Adacel and Keppra.'' The patient was treated with LEVETIRACETAM (KEPPRA [LEVETIRACETAM]) 500 mg for her seizures. The event outcome was unknown for seizure. Batch number has been requested for suspect product for this case.; Sender's Comments: This case concerns a unknown age old female patient who presented with seizure after vaccination with ADACEL. The time to onset is unknown. There is, however, no information regarding patient's condition at time of vaccination, past history and lab tests do not rule out alternate etiologies. Based upon the reported information, the role of the suspect vaccine cannot be assessed.

Other Meds:

Current Illness:

ID: 1489862
Sex: M
Age: 0
State: IL

Vax Date: 07/12/2021
Onset Date: 07/12/2021
Rec V Date: 07/21/2021
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Symptoms: A child received an expired dose of ACTHIB yesterday with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a physician via nurse via regulatory authority (Reference number- 00678904) and transmitted to Sanofi on 12-Jul-2021. This case involves a 2 months old male patient who received an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] yesterday (Expired product administered) Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ); PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) for prophylactic vaccination. On 12-Jul-2021, the patient received a first dose of suspect HIB (PRP/T) VACCINE (lot UJ359AA, expiry date: 11-Jul-2021) (Diluent- Lot: U6872AA, Expiration date: 01-Feb-2022, dose of diluent 0.6 ml) via intramuscular route in the left thigh for prophylactic vaccination. It was a case of an actual medication error due to Expired vaccine used (latency same day). It was reported that "Nurse called to report that an expired dose of a vaccine had been administered today (12JUL2021). The vaccine expired 11-Jul-2021. The caller would like to know if this dose is valid or if the child should be revaccinated?" At the time of report, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds: ROTATEQ; PREVNAR; PEDIARIX

Current Illness:

ID: 1489865
Sex: M
Age:
State: FL

Vax Date: 07/12/2021
Onset Date: 07/12/2021
Rec V Date: 07/21/2021
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Symptoms: male patient was accidently given Tenivac instead of TDap with no adverse event; Initial information received on 13-Jul-2021 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an adult male patient in his 40's who was accidently given DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] instead of DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID [TDAP]. Medical history, medical treatment, concomitant medication, vaccination and family history were not provided. On 12-Jul-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot number and expiry date: not reported) (Frequency: once) instead of TDAP not produced by Sanofi Pasteur via an unknown route at an unknown administration site (Wrong product administered) for prophylactic vaccination. It was an actual medication error case due to Wrong vaccine administered (latency on same day). It was reported that "Practitioner reported that a patient was accidently given TD instead of TDap on yesterday. Caller would like to know when can TDap now be administered to this patient. The Practitioner reported that the patient that received the Tenivac and not the ordered Tdap is in their 40s and is a male and that the dose of TDap was ordered was to be able to be near a newborn. The Practitioner was not able to provide any more information for this report due to not being in the clinic". At the time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 1489866
Sex: M
Age: 40
State: TX

Vax Date: 07/13/2021
Onset Date: 07/13/2021
Rec V Date: 07/21/2021
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Symptoms: 40 year old male patient administered expired diluent with no adverse event; Initial information received on 13-Jul-2021 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 40 year old male patient who was vaccinated with an expired diluent dose of suspect YELLOW FEVER VACCINE - US [YF-VAX]. Medical history, medical treatment, concomitant medication, vaccination and family history were not provided. On 13-Jul-2021, the patient received a 0.5 ml dose of suspect YELLOW FEVER VACCINE - US (lot number: UJ386AA and expiry date: 22-Aug-2022, Diluent Lot number: U6309AA and expiry date: 30-Jun-2021) (Frequency: once) via an subcutaneous route in the left arm (Expired product administered) for prophylactic vaccination. It was an actual medication error case due to Expired medical agent used (latency on same day). At the time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 1489867
Sex: M
Age: 17
State: VA

Vax Date: 06/16/2021
Onset Date: 06/16/2021
Rec V Date: 07/21/2021
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Symptoms: 17 year old male patient was inadvertently administered an expired dose of Menactra with no reported AE; Initial information received on 14-Jul-2021 regarding an unsolicited valid non-serious case received from a consumer in the United States. This case involves a 17 year old male patient who was inadvertently administered an expired dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA]. Patient received no concomitant vaccines. Medical history, medical treatment, concomitant medication, and family history were not provided. On 16-Jun-2021, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6365AA and expiry date: 24-Sep-2020) via an intramuscular route in the left deltoid (expired product administered) for prophylactic vaccination. It was an actual medication error case due to expired vaccine used (latency on same day). It was reported that "Caller stated the vaccine is expired and they administered it to a patient. Caller wants to know how effective the vaccine is, if they needed to give the vaccine to the patient again, or would they need to wait. Reported stated that as of today (14 Jul 2021) the patient has not reported any adverse effects from having received the expired vaccine." At the time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 1489868
Sex: U
Age:
State: IL

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Rec V Date: 07/21/2021
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Symptoms: IMOVAX for pre-exposure, incorrect schedule, dose on day 0, day 3, and day 7, no AE; Initial information received on 14-Jul-2021 regarding an unsolicited valid non-serious case from a pharmacist via Global Media Information (under reference number: 00681667). This case involves a patient of unknown age and gender patient who received RABIES (HDC) VACCINE [IMOVAX RABIES]'s incorrect schedule; that is on day 0, day 3, and day 7. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. The patient received first, second and third dose of suspect RABIES (HDC) VACCINE (lot number and expiration date not reported) via unknown route in an unknown administration site for pre-exposure immunization on day 0, day 3 and day 7 respectively (dates unknown) (inappropriate schedule of product administration). It was an actual medication error case due to inappropriate schedule vaccine administered. It was reported: "Pharmacist asked about the dosing series of IMOVAX for pre-exposure. An incorrect schedule was given to a patient. Patient was given a dose on day 0, day 3, and day 7. They are wondering if a 4th dose should be given, or would the patient be fully protected already. Pharmacist does not have the patient information at the moment." At time of reporting, it was unknown whether the patient had any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. There will be no information on the batch number for this case.

Other Meds:

Current Illness:

ID: 1489869
Sex: F
Age: 11
State: KS

Vax Date: 07/13/2021
Onset Date: 07/13/2021
Rec V Date: 07/21/2021
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Symptoms: 11 year old female patient inadvertently given DAPTACEL instead of a TDAP vaccine with no reported adverse event; 11 year old female patient inadvertently given DAPTACEL vaccine with no reported adverse event; Initial information received on 14-Jul-2021 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 11 year old female patient who was inadvertently given DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID [TDAP]. Medical history, medical treatment, vaccination and family history were not provided. Concomitant medications included MENINGOCOCCAL VACCINE (MENINGOCOCCAL VACCINE) for Immunisation; and HPV VACCINE (HPV VACCINE) for Immunisation. On 13-Jul-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5774AA and expiry date: 18-Sep-2022) (Frequency: once) via an intramuscular route in the right arm instead of TDAP not produced by Sanofi Pasteur (lot number and expiry date: not reported) via an unknown route at an unknown administration site (Wrong product administered and Product administered to patient of inappropriate age) for prophylactic vaccination. It was an actual medication error case due to Wrong vaccine administered and inappropriate age at vaccine administration (latency on same day). It was reported that "Patient age greater than one year enter as two month, four month, etc. Many pediatric vaccines need month for age. Pregnancy: not applicable, Last menstrual period, Due date, AE (adverse event) symptoms or no AE, If baby was delivered: delivery date and if baby experienced an adverse event, Inform that they will be receiving a follow up questionnaire, If calling specifically about being added to the pregnancy registry: all pregnancy cases are added to the registry, it is an FDA (food and drug administration) requirement. Reporter relationship: HCP (health care professional) Product used: Used First time product used: Yes". At the time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds: MENINGOCOCCAL VACCINE; HPV VACCINE

Current Illness:

ID: 1489870
Sex: F
Age:
State: MN

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Rec V Date: 07/21/2021
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Symptoms: inadvertently given an expired dose of Imovax Rabies with no reported adverse event; Initial information received on 14-Jul-2021 regarding an unsolicited valid non-serious case from a nurse. This case involves an unknown age female patient who was inadvertently given an expired dose of RABIES (HDC) VACCINE [IMOVAX RABIES] (expired product administered). The patient's past medical history included cat bite. The patient's past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On an unknown date, the patient received an expired dose of suspect RABIES (HDC) VACCINE (lot number not reported via unknown route in unknown administration site for post exposure immunization (expired product administered). It was reported that, "A patient was bitten by a cat and presented at the clinic on June 30th. She was inadvertently given an expired dose of Imovax Rabies. My colleague called, the patient was re-vaccinated with unexpired vaccine, on the same day. She also received immunoglobulin on that day. Today, she is back, 14 days later. How should I proceed with the series? Should I start over or give the day 3 dose?" It was a case of actual medication error due to expired vaccine used (latency same day). At the time of report, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. There will be no information available on the lot number for this case.

Other Meds:

Current Illness:

ID: 1489871
Sex: F
Age: 0
State: IN

Vax Date: 07/14/2021
Onset Date: 07/14/2021
Rec V Date: 07/21/2021
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Symptoms: Expired PENTACEL was administered to a patient with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from physician and other health care professional via Global Medical Information (GMI) (Reference number- 00682124) and transmitted to Sanofi on 14-Jul-2021. This case involved 4 month old female patient who administered expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE [PENTACEL] (expired product administered) Relevant medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); HEPATITIS B VACCINE and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) (reported as ROTOTECK) for prophylactic vaccination. On 14-Jul-2021, the patient received 0.5ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ341AAA and expiry date: 22-jun-2021) (Frequency: one) (strength: standard) via intramuscular route in the left thigh for prophylactic vaccination (expired product administered) It was reported that, "RMA (Registered Medical Assistant) stated that she accidentally gave an expired Pentacel injection to a patient today because she looked at the Pentacel wrong. Caller asked what she should do". It was an actual medication error case (expired vaccine used) (latency same day) At time of reporting, no adverse event This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds: PREVNAR 13; HEPATITIS B VACCINE; ROTATEQ

Current Illness:

ID: 1489872
Sex: M
Age: 68
State:

Vax Date: 07/15/2021
Onset Date: 07/15/2021
Rec V Date: 07/21/2021
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Symptoms: expired dose of ACT HIB had be administered with no reported adverse event; 68 year old patient administred ACT-HIB with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from physician and pharmacist via Global Medical Information (Reference number- 00684494) and transmitted to Sanofi on 15-Jul-2021. This case involved a 68 year old male patient who administered expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (product administered to patient of inappropriate age and expired product administered) Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided. On 15-Jul-2021, the patient received 0.5ml dose of suspect HIB (PRP/T) VACCINE (lot: UJ328AB and expiry date: 30-Jun-2021) (Frequency = once) (Strength = standard) via intramuscular route in the right deltoid for prophylactic vaccination (product administered to patient of inappropriate age and expired product administered) It was reported that, "the caller stated that an expired dose of ACT HIB had be administered. What are our recommendations"? This case was an actual medication error (expired vaccine used and Inappropriate age at vaccine administration) (latency same day) At the time of reporting, no adverse event This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 1490017
Sex: U
Age:
State: AL

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Symptoms: No additional AE reported. No PQC reported.; ROTATEQ had been administered to a patient since the excursion occured; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant therapy was not provided. On an unspecified date in 2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # T039454 has been verified to be a valid lot number, expiration date reported as 14-DEC-2021; strength, dose and route were not reported) for prophylaxis. The vaccine had been stored under 0.3 degree Celsius for 11 hours, 0.4 degree Celsius for 11 hours and 0.6 degree Celsius for 3 hours, recorded by digital data logger. The reporter was told that the vaccine was still viable. There was no previous temperature excursion. No additional adverse event (AE) or product quality complaint (PQC) was reported.

Other Meds:

Current Illness:

ID: 1490018
Sex: U
Age:
State: OH

Vax Date: 07/07/2021
Onset Date: 07/07/2021
Rec V Date: 07/21/2021
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Symptoms: No additional AE reported; An expired dose of VARIVAX was administered; This spontaneous report was received from a health care professional concerning a patient of unknown age and gender. Information regarding the patient's concomitant therapies, current conditions, medical history and historical drug was not provided. On 07-JUL-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX), 0.5 milliliters, lot S020465 expiration date 02-JUL-2021 (route of administration was not provided) as prophylaxis. Caller provided information from the post expiry memo. No additional adverse event was reported.

Other Meds:

Current Illness:

ID: 1490019
Sex: U
Age:
State:

Vax Date: 07/12/2021
Onset Date: 07/12/2021
Rec V Date: 07/21/2021
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Symptoms: No additional AE reported; adult patient located at an offsite facility received a pediatric dose of RECOMBIVAX HB.; adult patient located at an offsite facility received a pediatric dose of RECOMBIVAX HB.; This spontaneous report as received from a pharmacist refers to an adult patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 12-JUL-2021, the patient was vaccinated with a pediatric dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. No adverse effects were reported.

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Current Illness:

ID: 1490020
Sex: U
Age:
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Rec V Date: 07/21/2021
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Symptoms: Suspected vaccination failure; GOT shingles / nearly died and was in ICU for weeks; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria hospitalization, GSK medically significant and life threatening) and shingles (serious criteria hospitalization and life threatening). On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles. The reporter stated that, the patient nearly died and was in intensive care unit for weeks. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided. This case had been linked with case US2021AMR156171, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR156171:same reporter

Other Meds:

Current Illness:

ID: 1490021
Sex: M
Age:
State: CA

Vax Date:
Onset Date: 06/15/2021
Rec V Date: 07/21/2021
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Symptoms: RIGHT HAND FELT GREASY AND THEN FELT STICKY NEED TO CLEAN HAND SEVERAL TIMES A DAY; INSECURE FEELING DUE TO MUSCLE WEAKNESS (DIFFICULT TO TAKE A DECISION TO WALK FROM THE DINING TABLE TO THE BATHROOM OR OTHER AREAS); WEAKNESS INVOLVING WHOLE BODY; HAD PROBLEMS WHILE SPEAKING; RIGHT HAND AND LEG NUMBNESS; PARALYSIS RIGHT HALF OF THE BODY; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's past medical history included back injury, and pain due to back injury, and concurrent conditions included symptoms of covid-19 (runny nose). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A, expiry: unknown) dose was not reported, 1 total administered on 03-JUN-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 15-JUN-2021, at 21: 30 the patient experienced paralysis right half of the body and paralysis of the right leg. Did not feel any pain of previous back injury once the paralysis happened. On 16-JUN-2021, at 05:30- 06 the patient had problems while speaking, right hand and leg numbness and at unspecified time patient had trouble walking, hesitate difficult to get up from the couch or bed, insecure feeling due to muscle weakness (difficult to take a decision to walk from the dining table to the bathroom or other areas), tongue numbness, right arm weakness and sometimes left arm weakness and weakness that started on the right side and then involving whole body. On 19-JUN-2021, the patient felt right hand greasy and then felt sticky need to clean hand several times a day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from paralysis right half of the body, and paralysis of the right leg on 15-JUN-2021 lasted about 15 minutes, and had not recovered from had problems while speaking, weakness that started on the right side and then involving whole body, trouble walking, right hand and leg numbness, right hand felt greasy and then felt sticky need to clean hand several times a day, hesitate difficult to get up from the couch or bed, insecure feeling due to muscle weakness (difficult to take a decision to walk from the dining table to the bathroom or other areas), right arm weakness and sometimes left arm weakness, and tongue numbness. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210731397-covid-19 vaccine ad26.cov2.s-Hemiplegia. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

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Current Illness: Pain trauma activated; Runny nose

ID: 1490022
Sex: F
Age:
State: NJ

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Rec V Date: 07/21/2021
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Symptoms: OVERDOSE; OFF LABEL USE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced overdose, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from off label use, and overdose. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non-serious.

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Current Illness:

ID: 1490023
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 04/08/2021
Rec V Date: 07/21/2021
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Symptom List:

Symptoms: CHEST PRESSURE; INVOLUNTARY MOVEMENTS OF HEAD, ARMS AND LEGS; CHILLS; TIREDNESS; MUSCLE ACHES; FEVER; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced tiredness. On 08-APR-2021, the subject experienced muscle aches. On 08-APR-2021, the subject experienced fever. On 18-APR-2021, the subject experienced chest pressure. On 18-APR-2021, the subject experienced involuntary movements of head, arms and legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, tiredness, muscle aches, and fever on 11-APR-2021, and had not recovered from chest pressure, and involuntary movements of head, arms and legs. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.

Other Meds:

Current Illness:

ID: 1490024
Sex: M
Age:
State: CA

Vax Date:
Onset Date: 04/12/2021
Rec V Date: 07/21/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: SEIZURES; MINOR INJURIES; BRUISES WITH RUG BURN; FALLING ON THE CARPET; This spontaneous report received from a patient concerned a 38 year old male. The patient's weight was 210 pounds, and height was 76 inches. The patient's concurrent conditions included alcohol use occasional, and non-smoker, and the patient had no known allergies and no history of drug abuse or illicit drug use. Patient had no history of epilepsy as well. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808980, and expiry: Unknown) dose was not reported, 1 total administered on 06-APR-2021 for prophylactic vaccination on left deltoid. No concomitant medications were reported. On 12-APR-2021, after six days of vaccination patient started experiencing seizures. Patient's wife found patient in office face down laying on stomach and was unconscious. In less than two minutes patient woke up confused, and disoriented. Patient had suffered some minor injuries, and bruises with rug burn due to falling on the carpet. Patient was taken to the urgent care on 12-APR-2021. Since 12-APR-2021 patient had five more seizures. On 12-APR-2021, Laboratory data included: Electrocardiogram (EKG) (NR: not provided) within normal range. On 26-APR-2021, Laboratory data included: Blood lactate dehydrogenase (NR: not provided) within normal range, Complete blood count (CBC) (NR: not provided) within normal range, Chest X-ray (NR: not provided) within normal range, Emergency room Magnetic resonance imaging (MRI) (NR: not provided) within normal range, and Troponin (NR: not provided) within normal range. On 09-JUN-2021, Laboratory data included: Electroencephalogram (EEG) (NR: not provided) abnormal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the seizures, minor injuries, bruises with rug burn and falling on the carpet was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210738406-covid-19 vaccine ad26.cov2.s- seizures. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness: Alcohol use (Occasional); Non-smoker

ID: 1490025
Sex: M
Age:
State: FL

Vax Date:
Onset Date: 04/03/2021
Rec V Date: 07/21/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: OVERALL ACHINESS IN UPPER BODY; LABORED BREATHING; EXTREME PAIN IN JOINTS/PAIN IN RIGHT WRIST/SHOULDER PAIN/ELBOW PAIN; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180869 and expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced overall achiness in upper body. On 03-APR-2021, the subject experienced labored breathing. On 03-APR-2021, the subject experienced extreme pain in joints/pain in right wrist/shoulder pain/elbow pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from labored breathing, overall achiness in upper body, and extreme pain in joints/pain in right wrist/shoulder pain/elbow pain. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.

Other Meds:

Current Illness:

ID: 1490026
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 07/16/2021
Rec V Date: 07/21/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 40 year old White and Not Hispanic or Latino female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 02-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 16-JUL-2021, the patient was tested positive for COVID-19 (suspected COVID-19 infection and suspected clinical vaccination failure). The patient was close to someone who had COVID-19 with mild symptoms of a runny nose and cough. The symptoms were mild and patient got tested because she had children at home. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from suspected COVID-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210738685-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness:

ID: 1490027
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/21/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: BODY ACHES; FELT BLAH; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, and felt blah. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and felt blah. This report was non-serious. This case, from the same reporter is linked to 20210740692.

Other Meds:

Current Illness:

ID: 1490028
Sex: F
Age:
State: WA

Vax Date:
Onset Date: 07/02/2021
Rec V Date: 07/21/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
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Lab Data:

Allergies:

Symptom List:

Symptoms: VACCINE ADMINISTERED TO 16 YEAR OLD PATIENT; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 16 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no medical history. the patient have no history of drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 02-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUL-2021, the subject experienced vaccine administered to 16 year old subject. On 02-JUL-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and vaccine administered to 16 year old patient was not reported. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Non-smoker

ID: 1490029
Sex: M
Age:
State:

Vax Date:
Onset Date: 07/01/2021
Rec V Date: 07/21/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: UNDER MINIMUM CONDITIONS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 14-JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On JUL-2021, the subject experienced under minimum conditions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from under minimum conditions. This report was non-serious. This case, from the same reporter is linked to 20210743283.

Other Meds:

Current Illness:

ID: 1490030
Sex: F
Age: 63
State: CA

Vax Date: 04/05/2021
Onset Date: 04/05/2021
Rec V Date: 07/21/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: Swelling of upper airways (lips, tongue, throat,uvula or larynx); Angioedema; Allergic reaction; Mild tongue swelling; Weird sensation in tongue; Glands were swollen; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANGIOEDEMA (Angioedema) and RESPIRATORY TRACT OEDEMA (Swelling of upper airways (lips, tongue, throat,uvula or larynx)) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced ALLERGY TO VACCINE (Allergic reaction), SWOLLEN TONGUE (Mild tongue swelling), PARAESTHESIA ORAL (Weird sensation in tongue), LYMPHADENOPATHY (Glands were swollen) and FATIGUE (Fatigue). On 05-Apr-2021 at 10:25 AM, the patient experienced ANGIOEDEMA (Angioedema) (seriousness criterion medically significant). On an unknown date, the patient experienced RESPIRATORY TRACT OEDEMA (Swelling of upper airways (lips, tongue, throat,uvula or larynx)) (seriousness criterion medically significant). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) (oral) on 05-Apr-2021 at a dose of 10 mg once a day. On 05-Apr-2021 at 11:05 AM, ANGIOEDEMA (Angioedema) had resolved. At the time of the report, RESPIRATORY TRACT OEDEMA (Swelling of upper airways (lips, tongue, throat,uvula or larynx)) had resolved, ALLERGY TO VACCINE (Allergic reaction), SWOLLEN TONGUE (Mild tongue swelling) and LYMPHADENOPATHY (Glands were swollen) had not resolved and PARAESTHESIA ORAL (Weird sensation in tongue) and FATIGUE (Fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-May-2021, Blood pressure measurement: 100/73 (Low) 100/73 and 109/77 (Low) 109/77. On 04-May-2021, Heart rate: 65 (Inconclusive) 65 and 66 (Inconclusive) 66. On 04-May-2021, Respiratory rate: 12 (Inconclusive) 12 and 12 (Inconclusive) 12. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. On 04-Apr-2021 at 10:25 a.m Patient vitals were Heart rate 65.,resiratory rate 12 and blood pressure of 100/73. On 04-Apr-2021 at 10:35 a.m. Patient vitals were Heart rate 66, respiratory rate 12 and blood pressure 109/77.On 05-Apr-2021 at 10:25 a.m Patient had Angioedema. It resolved after 40 minutes at 11:05 a.m. The first observation of angioedema was mild tongue swelling followed by swelling of upper airways(lips, tongue, throat, uvula or larynx ).Patient went to Doctor's office/ urgent care /return to vaccine clinic and Follow up with Allergist on 14-04-2021. Treatment for the event included cetirizine (Zyrtec). Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Follow-up information received on 20MAY2021 contains no new information. On 14-Jul-2021: Follow-up information was received: Patient demographics, lab data, vaccine batch number, treatment drug and new events Angioedema, Airway edema and Fatigue were added. This case was upgraded from non-serious to serious due to the addition of new events angioedema and airway edema; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1490031
Sex: F
Age: 57
State: FL

Vax Date: 04/14/2021
Onset Date: 04/14/2021
Rec V Date: 07/21/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: Unfortunately your medicine caused a stroke to my brain; Drug dose omission; Headache (hasn't gone away); Vomiting; Running nose; Diarrhea; Ache; Running temperature; Chills; Developed fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Unfortunately your medicine caused a stroke to my brain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (Lasted for two weeks.) from 28-Mar-2021 to April 2021. On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced RHINORRHOEA (Running nose), DIARRHOEA (Diarrhea), PAIN (Ache), PYREXIA (Running temperature), CHILLS (Chills), FATIGUE (Developed fatigue) and VOMITING (Vomiting). On 29-Apr-2021, the patient experienced HEADACHE (Headache (hasn't gone away)). On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Unfortunately your medicine caused a stroke to my brain) (seriousness criterion medically significant) and PRODUCT DOSE OMISSION ISSUE (Drug dose omission). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, CEREBROVASCULAR ACCIDENT (Unfortunately your medicine caused a stroke to my brain) outcome was unknown, RHINORRHOEA (Running nose), DIARRHOEA (Diarrhea), PAIN (Ache), PYREXIA (Running temperature), CHILLS (Chills), FATIGUE (Developed fatigue), VOMITING (Vomiting) and PRODUCT DOSE OMISSION ISSUE (Drug dose omission) had resolved and HEADACHE (Headache (hasn't gone away)) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Mar-2021, SARS-CoV-2 test: positive (Positive) positive. In April 2021, SARS-CoV-2 test: negative (Negative) Negative. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: Follow up received contains no new information. On 18-Jul-2021: Follow up received, new event cerebrovascular accident added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1490032
Sex: M
Age: 61
State: NY

Vax Date: 04/08/2021
Onset Date: 04/08/2021
Rec V Date: 07/21/2021
Hospital: Y

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: NKDA

Symptom List:

Symptoms: Developed weakness in legs, needed help with walking, legs got weak like rubber, couldn't hold self up. ambulance to hospital, next day, could walk again. Was sent home after 3 days with home PT, had return of weakness, slid off bed, couldn't stand up. Was sent to Rehab- 2 weeks, 75% back to baseline and is extremely tired, sleeping easily

Other Meds: Taking Lantus Solostar Pen 100 units/mL solution 26 units b.i.d Taking metformin 500 mg tablet 1 tab(s) orally bid Taking pantoprazole 40 mg delayed release tablet 1 tab(s) orally once a day Taking atorvastatin 40 mg tablet 1 tab(s

Current Illness:

ID: 1490033
Sex: M
Age: 57
State: MD

Vax Date: 07/19/2021
Onset Date: 07/20/2021
Rec V Date: 07/21/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: codeine

Symptom List:

Symptoms: Muscle aches, headache, chills lasting from the morning of 7/20/2021 to morning of 7/21/2021. I took Tylenol for pain, which seemed to help. Slept at least 10 hours on the night of 7/20-7/21. Feeling a little better the morning of 7/21.

Other Meds: furosemide, spironolactone, protonix, carvedilol, lactulose, tamsulosin, ferrous sulfate, folic acid, D2, B12, acetaminofen

Current Illness: None

ID: 1490034
Sex: F
Age: 33
State: VT

Vax Date: 04/19/2021
Onset Date: 06/06/2021
Rec V Date: 07/21/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: Sick for the two days; Had period the following week and was extremely emotional and had a heavy period; Felt awful the rest of the day; Extremely emotional; Seizure; Not feeling well; Twitching my hands.; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizure) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038c21a and 019b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Sulfonamide allergy. Concomitant products included ETHINYLESTRADIOL, LEVONORGESTREL (VIENVA) from 15-Mar-2021 to an unknown date for Birth control, MINERALS NOS, VITAMINS NOS (ONE A DAY [MINERALS NOS;VITAMINS NOS]) from 01-May-2015 to an unknown date and COLLAGEN from 15-Mar-2021 to an unknown date for an unknown indication. On 19-Apr-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021 at 3:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jun-2021, the patient experienced MALAISE (Not feeling well) and MUSCLE TWITCHING (Twitching my hands.). On 06-Jun-2021 at 2:30 PM, the patient experienced SEIZURE (Seizure) (seriousness criterion medically significant). On an unknown date, the patient experienced ILLNESS (Sick for the two days), HEAVY MENSTRUAL BLEEDING (Had period the following week and was extremely emotional and had a heavy period), FEELING ABNORMAL (Felt awful the rest of the day) and EMOTIONAL DISORDER (Extremely emotional). At the time of the report, SEIZURE (Seizure), ILLNESS (Sick for the two days), HEAVY MENSTRUAL BLEEDING (Had period the following week and was extremely emotional and had a heavy period), MALAISE (Not feeling well), MUSCLE TWITCHING (Twitching my hands.), FEELING ABNORMAL (Felt awful the rest of the day) and EMOTIONAL DISORDER (Extremely emotional) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Magnetic resonance imaging: negative (Negative) Negative. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Very limited information regarding the event has been provided at this time. Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Follow Up document was received and had significant information. Added Lab data. On 18-Jul-2021: Follow-up document was received and had significant information. Added vaccine facility, patient demographics, medical history, concomitant medications, event start date. Added new events like sick, heavy period, not feeling well, hand twitching, emotional.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Very limited information regarding the event has been provided at this time.

Other Meds: VIENVA; ONE A DAY [MINERALS NOS;VITAMINS NOS]; COLLAGEN

Current Illness: Sulfonamide allergy

ID: 1490035
Sex: F
Age: 80
State: PA

Vax Date: 03/15/2021
Onset Date: 06/14/2021
Rec V Date: 07/21/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: No Known Allergies

Symptom List:

Symptoms: Cough, congestion, head cold, fever methylprednisolone Monitor home O2 level

Other Meds: ascorbic acid, vitamin C, (VITAMIN C) 500 mg tablet atorvastat

Current Illness: None

ID: 1490036
Sex: M
Age: 0
State: LA

Vax Date: 10/19/1960
Onset Date: 04/06/2021
Rec V Date: 07/21/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: none

Symptom List:

Symptoms: Burning sensation all over my body

Other Meds: none

Current Illness: none

ID: 1490037
Sex: F
Age: 76
State: PA

Vax Date: 03/27/2021
Onset Date: 07/12/2021
Rec V Date: 07/21/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: AtorvastatinMyalgia / Muscle Pain IbuprofenHallucinations LisinoprilHives / Urticaria PravastatinMyalgia / Muscle Pain AmlodipineNausea Only EzetimibeDizziness / Lightheaded NiacinDizziness / Lightheaded

Symptom List:

Symptoms: Fever or Chills Fatigue Muscle or body aches Headache Congestion or running nose

Other Meds: ascorbic acid/collagen hydr (COLLAGEN PLUS VITAMIN C ORAL) aspirin 81 mg tablet ibuprofen (MOTRIN) 600 mg tablet multiple vitamins (MULTI-DELYN) liquid VIT C/VIT E AC/LUT/COPPER/ZINC (PRESERVISION LUTEIN ORAL)

Current Illness: None

ID: 1490038
Sex: M
Age: 61
State: IN

Vax Date: 07/19/2021
Onset Date: 07/20/2021
Rec V Date: 07/21/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: Compazine

Symptom List:

Symptoms: Slight nausea and severe malaise.

Other Meds: Vit C, 82mg aspirin, Latanoprost, multivitamin

Current Illness: None

ID: 1490039
Sex: F
Age: 85
State: PA

Vax Date: 04/24/2021
Onset Date: 07/08/2021
Rec V Date: 07/21/2021
Hospital: Y

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies: Hydrocodone-acetaminophenIndigestion / GI upset Iodinated Contrast MediaOther (document details in comments), Anaphylaxis IodineOther (document details in comments) Iodine Containing MultivitaminAnaphylaxis LisinoprilCoughing MeperidineNausea and Vomiting, Other (document details in comments) MorphineIndigestion / GI upset PenicillinsItching Propoxyphene N-acetaminophenNausea and Vomiting Sulfa (Sulfonamide Antibiotics)Itching PropoxypheneNausea And Vomiting Tramadol HydromorphoneOther (document details in comments)

Symptom List:

Symptoms: Acute respiratory failure with hypoxia wet cough Shortness of breath

Other Meds: acetaminophen (TYLENOL EXTRA STRENGTH) 500 mg tablet albuterol 2.5 mg /3 mL (0.083 %) nebulizer solution albuterol HFA (PROAIR HFA) 90 mcg/actuation inhaler allopurinoL (ZYLOPRIM) 100 mg tablet amLODIPine (NORVASC) 10 mg tablet aspirin 81 m

Current Illness: suspected liver cirrhosis.

ID: 1490040
Sex: F
Age: 22
State: PA

Vax Date: 07/20/2021
Onset Date: 07/20/2021
Rec V Date: 07/21/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: temporary loss of vision-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Medium, Additional Details: pt was given vaccine and approximately 5minutes or less later patient fell out of chair and onto floor. patient was pale,unresponsive for less than 30 seconds and clammy to touch. her lips were blue. 911 was called. came to almost immediately and did not remember what happened. vision went black but came back after a few minutes. tested her blood sugar is was 114. pulse was rapid. anbulance arrived pt walked out on her own power. refused treatment from emts and refused to go to er.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 599,999

Page last modified: 03 October 2021 5:28pm